Scientist II
- calibration
- GMP
Not enough detail in this posting to match
Title -Scientist II
Duration: 12 Months
Location: Raritan, NJ
Department: Manufacturing Quality
Reports To: Supervisor, Microbiology
Shift: First Shift
POSITION SUMMARY
Responsible for routine and non-routine microbiological testing according to established procedures and approved protocols. Supports manufacturing quality operations through testing, environmental monitoring, investigations, product release activities, data review, equipment maintenance, and microbiological documentation.
KEY RESPONSIBILITIES
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Perform raw material, intermediate, final product, and water testing, including Bioburden and Endotoxin testing.
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Perform environmental monitoring (viable and non-viable).
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Document results accurately and interpret findings against specifications and requirements.
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Investigate and close Microbial Data Excursions (MDEs) using MODA and/or TrackWise.
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Perform data reviews and prepare product release documentation to meet production timelines.
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Participate in laboratory investigations, technology transfer activities, validations, and R&D projects.
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Identify microorganisms and enter data into MODA.
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Maintain trending spreadsheets and laboratory binders.
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Report and trend finished product testing and environmental monitoring results for manufacturing and support areas.
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Calibrate and maintain laboratory equipment.
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Monitor and maintain laboratory inventory and supplies.
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Perform additional work-related duties as assigned.
TIME ALLOCATION
|
Time |
Responsibility |
|---|---|
|
35% |
Raw material, intermediate, final product, water testing, Bioburden, Endotoxin testing, and environmental monitoring. |
|
25% |
Investigation and closure of Microbial Data Excursions (MDEs) in MODA and/or TrackWise. |
|
10% |
Data review and preparation of product release documentation. |
|
10% |
Participation in laboratory investigations, technology transfers, validations, and R&D projects. |
|
10% |
Microorganism identification, MODA data entry, and maintenance of trending records. |
|
5% |
Reporting and trending of finished product and environmental monitoring results. |
|
5% |
Calibration, maintenance of laboratory equipment, and inventory management. |
QUALIFICATIONS
Education
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Bachelor's Degree in Biology, Microbiology, Life Sciences, or related scientific discipline.
Experience
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3β5 years of laboratory experience in a regulated environment, or an equivalent combination of education and experience.
SKILLS AND KNOWLEDGE
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Microbiology testing
-
Bioburden testing
-
Endotoxin testing
-
Environmental monitoring
-
Product release testing
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Laboratory investigations
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Microbial identification
-
MODA
-
TrackWise
-
GMP / regulated laboratory environment
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Documentation and data review
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Laboratory equipment calibration
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Trending and reporting
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Inventory management
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Strong written and verbal communication skills
PHYSICAL REQUIREMENTS
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Lift up to 50 pounds.
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Manual dexterity for handling laboratory instruments and repetitive tasks.
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Ability to stand for extended periods.
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Strong written and verbal communication skills.
KEY WORKING RELATIONSHIPS
Internal
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Manufacturing/Operations β Product release testing support.
External
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Vendors and suppliers β Equipment maintenance and laboratory supplies support.
TRAVEL
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No travel required.
Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Scientist II Β· TalentBurst, Inc.